BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1023767 · Received March 21, 2008

    Report

    Report Number
    1119421-2008-00173
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE RETURNED PHOTOS WERE REVIEWED AND THE LENS APPEARS TO BE DAMAGED. HOWEVER, NO DETERMINATION COULD BE MADE AS TO THE ORIGIN OF THE DAMAGE. THERE ARE NO OTHER REPORTS IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

    Description of Event or Problem · 1

    SURGEON REPORTED PATIENT COMPLAINS OF LINES IN HIS VISION WHEN HE LOOKS AT A LIGHT. PATIENT REPORTED SEEING DIAGONAL LINES THAT ARE DISTORTING HIS VISION AND HE IS EXPERIENCING GLARE. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60T3 10735692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other